FDA.reportPublic FDA data

GENOSYL®

Primary DI
00850000962019
Brand
GENOSYL®
Company
VERO BIOTECH INC.
Model
602747-01
Catalog number
602747-01
Device description
Gas Line Set with Integrated Humidification Reservoir
Published
2023-07-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRNApparatus, Nitric Oxide Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRNApparatus, Nitric Oxide DeliveryAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000962019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000962019008500009620198500009620190850000962019

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
678-661-5721robyn.mcclure@vero-biotech.com

Regulatory Flags#

DUNS number
872672477
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000962330GENOSYL®602524-01602524-012026-05-06
00850000962347GENOSYL®602013-04602013-042026-05-06
00850000962484GENOSYL®601758-04601758-042026-05-06
00850000962316GENOSYL®602716-01602716-012023-07-24
00850000962095GENOSYL®601954-01601954-012020-09-14
00850000962125GENOSYL®602039-01602039-012020-09-14
00850000962132GENOSYL®602069-01602069-012020-09-14
00850000962156GENOSYL®601746-02601746-022020-09-14
00850000962088GENOSYL®601758-02601758-022020-06-15
00850000962033GENOSYL®6016906016902020-05-14
00850000962262GENOSYL®600943-01600943-012023-10-06
00850000962279GENOSYL®601745-01601745-012023-10-06
00850000962309GENOSYL®601970-01601970-012023-10-06
00850000962323GENOSYL®601503-01601503-012023-10-06
00850000962064GENOSYL®6019556019552023-07-24
00850000962194GENOSYL®6024896024892023-03-16
00850000962170GENOSYL®602166-01602166-012023-03-14
00850000962286GENOSYL®601743-01601743-012023-10-06
00850000962293GENOSYL®601747-01601747-012023-10-06
00850000962101GENOSYL®602001-01602001-012023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00810055280100INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280148INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280155INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280063INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280070INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280087INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280094INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280107INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280145INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280152INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280162INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280179INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
03760333380671Ulspira TSAirgas Therapeutics, LLCMRN2024-01-02
00850000962262GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962279GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962286GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962293GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962309GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962323GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962064GENOSYL®VERO BIOTECH INC.MRN2023-07-24
00850000962101GENOSYL®VERO BIOTECH INC.MRN2023-07-24